Natera - Senior Quality Assurance Specialist
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Requirements
• Bachelor's degree in science, engineering, medical technologist, other relevant discipline, or equivalent required. • 5+ years of work experience in Clinical Laboratory or Biotech industry preferred or a relevant combination of skills, education, and experience • Prior quality or operational experience in a medical setting is a plus. • The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. • $79,500 - $99,400 USD • OUR OPPORTUNITY • OUR OPPORTUNITY • Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. • The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.
Responsibilities
• Operation and monitoring of facility, product, equipment and associated software. • Timely responses to resolution of alarm notifications from the facility systems and product storage systems. • Support in product inventory activities. • Execution of product movement during emergencies and planned maintenance. • Maintenance of equipment and safety equipment to ensure quality product storage and employee safety. • Host and lead state and federal inspectors during inspections. • Continuously evaluate progress toward objectives adapting them to meet customer and business needs. • Maintain positive and cooperative communication and collaboration with all levels of employees, customer, contractors and vendors. • Serve on Teams such as CAPA, Deviations, and Nonconformances; represents or serves as escalation for Quality on Core Teams. • Maintain an influential and effective network and communication with leadership team members for identifying quality improvement opportunities to evaluate, propose and implement new processes and technologies to optimize efficiencies. • Support the set up and maintenance Quality Systems for Document Control, CAPA, Internal Audit, and Complaint investigations. • Comply with all quality policies, procedures, and practices through consistent application of sound quality assurance principles. • This role will have occasional access to PHI both in paper and electronic form and have occasional access to various technologies to access PHI (paper and electronic) in order to perform the job. • Employee must complete training relating to HIPAA/PHI privacy, General Policies and Procedure Compliance training and security training as soon as possible but not later than the first 30 days of hire.
Benefits
• Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! • For more information, visit www.natera.com.
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